A randomized controlled trial-comparison of two types a bleeding-arresting devices (Hemopath vs. Tachosil) in liver operations.

Phase 1

Conditions: Bleeding during liver resection and the efficacy of 2 types of hemostatic patches on this, thus all diagnosis' that require liver resection.
MedDRA version: 17.1Level: LLTClassification code 10060663Term: Surgical hemostasisSystem Organ Class: 100000004865
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

Registration Number: EUCTR2015-000091-10-DK

Lead Sponsor: Rigshospitalet, department of surgical Gastroenterology, C-Tx

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Electice patients scheduled for liver resection, who have signed the written consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

Lack of need for a hemostatic patch/ hemostasis during the procedure.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess whether the medical device Hemopatch, has a higher efficacy in obtaining hemostasis during liver resection than Tachosil;Secondary Objective: To assess whether the medical device Hemopatch, has a lower rate of post-operative complications than Tachosil within 30 days.;Primary end point(s): Immediate failure-rate of Hemostatic patch. Failure is defined as:<br><br>•Inability to stop non-arterial bleeding from the area covered by the agent/patch - Blood oozing from the rims of the patch or hematoma formation between the patch and the surface.<br>•The patch slips completely or partly from the covered area. All 4 sides of the patch should adhere tightly to the surface. <br>•The patch perforates or disintegrates during manipulation.<br>;Timepoint(s) of evaluation of this end point: Each patch is assessed after application, thus per-operative evaluation.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): <br>•Perioperative bleeding.<br>•Postoperative bile leakage<br>•Length of admission/in-hospital stay.<br>•Intraabdominal absces formation. <br>;Timepoint(s) of evaluation of this end point: 30 day follow up after surgery.